Novartis Phase IIa
Study period:Ongoing.
KAE609 will be evaluated primarily for hepatic safety of single and multiple doses in sequential cohorts with increasing doses. This study aims to determine the maximum safe dose of the investigational drug KAE609 in malaria patients.
Objectives
- To characterize hepatic safety aspects of single-and multiple ascending doses of KAE609 in adult malaria patients..
- To evaluate overall safety and tolerability of KAE609.
- To assess key pharmacokinetic (PK)parameters following treatment with KAE609.
- To assess the efficacy of KAE609 in patients with uncomplicated falciparummalaria.
- To assess recrudescence after single and multiple doses of KAE609.
